Land: Malaysia
Sprache: Englisch
Quelle: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Lorlatinib
PFIZER (MALAYSIA) SDN. BHD.
Lorlatinib
30 Tablets; 10 Tablets
Pfizer Manufacturing Deutschland GmbH.
Pfizer Confidential _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ LORVIQUA ® FILM COATED TABLET Lorlatinib (25 mg and 100 mg) WHAT IS IN THIS LEAFLET 1. What LORVIQUA is used for 2. How LORVIQUA works 3. Before you use LORVIQUA 4. How to use LORVIQUA 5. While you are using it 6. Side Effects 7. Storage and Disposal of LORVIQUA 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT LORVIQUA IS USED FOR LORVIQUA is used to treat adults with lung cancer called advanced non-small cell lung cancer (NSCLC) whose tumors are caused by a gene defect called anaplastic lymphoma kinase (ALK). Lorviqua can be prescribed to you if: - you have not been previously treated with an ALK inhibitor; or - you have been previously treated with a medicine called alectinib or ceritinib, which are ALK inhibitors; or - you have been previously treated with crizotinib followed by another ALK inhibitor. HOW LORVIQUA WORKS LORVIQUA blocks the action of an enzyme called ALK tyrosine kinase and therefore inhibits tumour growth. In addition to that, LORVIQUA helps to address issues of resistance after previous treatment with other ALK inhibitors. LORVIQUA is also able to penetrate the brain to cause tumour shrinkage hence prolonging survival. BEFORE YOU USE LORVIQUA _- When you must not use it _ Do not take LORVIQUA - if you are allergic to LORVIQUA or any of its ingredients - if you are currently taking certain other medicines called strong CYP3A inducers. It may damage your liver - if you have moderate to severe liver problems - if you are pregnant - while you are breastfeeding Ask your doctor or pharmacist for advice before taking any medicine. _- Before you start to use it _ As male fertility may be reduced during treatment with LORVIQUA, men should seek advice on fertility preservation before treatment Ensure that you have discontinued usage of any CYP3A inducers (for e.g., rifampin) for a sufficient amount of time advised by your doctor before starting LORVIQUA Before taking Lesen Sie das vollständige Dokument
PFIZER LORVIQUA ® 1. NAME OF THE MEDICINAL PRODUCT LORVIQUA 25 MG FILM COATED TABLETS LORVIQUA 100 MG FILM COATED TABLETS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 25 mg film-coated tablet contains 25 mg of lorlatinib. Each 100 mg film-coated tablet contains 100 mg of lorlatinib. For the full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet 25 mg: 8 mm round tan immediate release film-coated tablet, debossed with “Pfizer” on one side and “25” and “LLN” on the other side. 100 mg: oval (8.5 × 17 mm) lavender immediate release film-coated tablet, debossed with “Pfizer” on one side and “LLN 100” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS LORVIQUA as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor. LORVIQUA as monotherapy is indicated for the treatment of adult patients with ALK positive advanced NSCLC whose disease has progressed after: • alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy; or • crizotinib and at least one other ALK TKI 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with lorlatinib should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. ALK testing Detection of ALK positive NSCLC is necessary for selection of patients for treatment with lorlatinib because these are the only patients for whom benefit has been shown. Assessment for ALK positive NSCLC should be performed by laboratories with 1 demonstrated proficiency in the specific technology being utilized. Improper assay performance can lead to unreliable test results. Recommended dosing The recommended dose schedule of LORVIQUA is 100 mg taken orally once daily continuously. Continue treatment as long as the patient is deriving clinical benefit from therapy. LORVIQUA may be taken with or without food (see Section 5.2). Patients sh Lesen Sie das vollständige Dokument